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VOL. XIV NO. 4
www.healthcareenvironmentalsolutions.com
WINTER 2018/19
New EPA Pharmaceutical Waste Rule Impacts Healthcare Providers By Sandy Woodthorpe
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igned by the EPA Acting Administrator Andrew Wheeler on December 11, 2018, the EPA’s final rule addresses and clarifies compliance with the agency’s Resource Conservation and Recovery Act (RCRA) hazardous waste regulations for certain pharmaceuticals generated at healthcare facilities and managed at reverse distributors. According to EPA, this final rule establishes cost-saving, streamlined standards for handling hazardous waste pharmaceuticals to better fit the operations of the healthcare sector while maintaining protection of human health and the environment. EPA asserts that this final rule will make our drinking and surface water safer and healthier by reducing the amount of hazardous waste pharmaceuticals entering our waterways by 1,644 to 2,300 tons (on an annual basis), by prohibiting all facilities, subject to the rule, from sewering such waste. EPA further states that this action will help address the issue highlighted by a growing body of publicly available studies documenting the presence of pharmaceuticals in drinking and surface waters,
as well as their negative impacts to aquatic and riparian ecosystems. The EPA rule also adds another layer of control to prevent prescription drugs from reaching the black market, which it claims is a contributing factor to the U.S. opioid crisis. In addition, under this final rule, FDAapproved, over-the-counter nicotine replacement therapies (i.e., nicotine patches, gums and lozenges) will no longer be considered hazardous waste when discarded, which it claims will result in significant cost savings and burden reduction in the management of these types of nicotine wastes.
The new requirements apply to prescription pharmaceuticals only. The rule does not apply to potentially reusable and reclaimable over-thecounter drugs and dietary supplements, dental amalgam or sharps. The final rule reaffirms EPA’s existing policy that non-prescription pharmaceuticals and other unsold retail items that have a reasonable expectation of being legitimately used/reused or reclaimed are not solid waste. It also provides regulatory certainty that the Resource Conservation and Recovery Act (RCRA) applies when healthcare facilities send unused, unsaleable prescription hazardous waste pharmaceuticals to reverse distributors to receive manufacturer credit. Simultaneously, the rule incorporates flexibilities to accommodate current reverse distribution business practices to facilitate its implementation. The waste classification and requirements spelled out in the EPA’s final rule also impose new evaluation, documentation, record-keeping and training requirements on the following: hospitals and outpatient facilities; nursing care and long-term care facilities; medical, dental and veterinary, ambulatory and chiropractic clinics and offices; pharmacies and drug stores; supermarkets, grocery stores and warehouse club retailers, as well as drug wholesalers and reverse distributors.
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